NovaDel Pharma (NovaDel) has enter into an exclusive license and distribution agreement with ECR Pharmaceuticals, a wholly owned subsidiary of Hi-Tech Pharmacal to commercialise and manufacture ZolpiMist in the US and Canada.
ZolpiMist is oral spray formulation of zolpidem tartrate approved by the FDA in December of 2008.
Under the terms of the agreement, ECR is expected to pay NovaDel $3m upon the execution of the agreement. ECR will assume responsibility for manufacturing and marketing the product in the US and Canada.
In addition, ECR is also expected to pay royalties of up to 15% on net sales of ZolpiMist as well as an additional milestone payment if sales reach a specified level.
Steven Ratoff, chairman and interim CEO of NovaDel, said: “This is an important milestone for our company as it recognises the opportunity of the use of our NovaMist oral spray technology in what we believe to be an important and sizable clinical application. We believe that Hi-Tech has the ability to build a solid position for ZolpiMist in the market for prescription sleep aids.
“This agreement, in addition to the recently announced license of NitroMist, will allow us to initiate further development of our product pipeline utilising our patented NovaMist oral spray technology.”